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Completed

NCT Number: NCT02347124

Promoting Oral Health Among Smokers Randomized Trial

The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines.

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome]. 2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome]. 3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

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Key information

Conditions

Oral Disease Behavior Health Behavior Mouth Diseases Smoking Smoking Cessation Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

About this study

Smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. Eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program.

Follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. In addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the Oral Health 4 Life program will be examined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18 or older
  • Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
  • Can read and speak in English
  • Current daily smoker and smokes at least 5 cigarettes a day
  • Interested in quitting smoking in next 30 days
  • Have some or all natural teeth
  • Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months
  • Has a cell phone capable of receiving text messages and provides cell phone number
  • Has internet access for personal use
  • Willing to talk about ways to improve their oral health
  • Provides verbal consent to participate

Exclusion criteria

  • Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
  • Have lived at the current address less than 6 months or plans to move in the next 6 months
  • Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
  • Has a household member already enrolled in the study, based on self-report and/or mailing address on file

Treatment and study plan

Usual Care Control

Behavioral

Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.

Enhanced Intervention

Behavioral

Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)

Primary outcomes

  1. 7 Day Point Prevalent Abstinence (PPA)

    Time frame: 6 month post-enrollment

    7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.

  2. Professional Dental Care Utilization in Past 6 Months

    Time frame: 6 months post-enrollment

    self-reported utilization of professional dental care during study observation period

Secondary outcomes

  1. 7 Day Point Prevalent Abstinence (PPA)

    Time frame: 2 months post-enrollment

    7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers

  2. 7 Day Point Prevalent Smoking Abstinence (PPA)

    Time frame: 2 months post-enrollment

    Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.

  3. 7 Day Point Prevalent Smoking Abstinence (PPA)

    Time frame: 6 months post-enrollment

    Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.

Other outcomes

  1. Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up

    Time frame: Baseline to 2 months

    Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:

    Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.

    Responses and scoring to the adapted NHIS scale:

    Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5

    Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.

    The scores have a range of 7 (minimum) to 35 (maximum).

    The study outcome is the change in this score between BL and 2 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge.

  2. Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up

    Time frame: Baseline to 6 months

    Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:

    Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.

    Responses and scoring to the adapted NHIS scale:

    Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5

    Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.

    The scores have a range of 7 (minimum) to 35 (maximum).

    The study outcome is the change in this score between BL and 6 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge.

  3. Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up

    Time frame: Baseline to 2 months

    SE to see a dentist was assessed using the following question:

    "As of today, how confident are you that you can…See a dentist in the next 6 months?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

    The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

  4. Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up

    Time frame: Baseline to 6 months

    SE to see a dentist was assessed using the following question:

    "As of today, how confident are you that you can…See a dentist in the next 6 months?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

    The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

  5. Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up

    Time frame: Baseline to 2 months

    Motivation to stop smoking was assessed using the following question:

    "As of today, how motivated are you to…Stop smoking for good or remain quit?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

    The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.

    The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

  6. Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up

    Time frame: Baseline to 6 months

    Motivation to stop smoking was assessed using the following question:

    "As of today, how motivated are you to…Stop smoking for good or remain quit?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

    The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.

    The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

  7. Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up

    Time frame: Baseline to 2 months

    Motivation to see a dentist was assessed using the following question:

    "As of today, how motivated are you to…see a dentist in the next 6 months?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

    The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.

    The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

  8. Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up

    Time frame: Baseline to 6 months

    Motivation to see a dentist was assessed using the following question:

    "As of today, how motivated are you to…see a dentist in the next 6 months?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

    The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.

    The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

  9. Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up

    Time frame: Baseline to 2 months

    SE to quit smoking was assessed using the following question:

    "As of today, how confident are you that you can…stop smoking for good or remain quit?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

    The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.

    The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

  10. Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up

    Time frame: Baseline to 6 months

    SE to quit smoking was assessed using the following question:

    "As of today, how confident are you that you can…stop smoking for good or remain quit?"

    Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

    The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.

    The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Consumer Wellness Solutions
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of California

Registry information

Official study title

Promoting Oral Health Among Tobacco Quitline Callers

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2015
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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